Clinical Evaluations on the Diagnosis of Autism

Background. Mucositis is an adverse effect of chemotherapy (QT) and/or radiotherapy (RT). The purpose of this study was to investigate the occurrence of oral mucositis in children undergoing cancer treatment. Methods. Fifty-one children with cancer who had received QT, RT, or both (QT-RT) underwent clinical evaluations; World Health Organization criteria were used to establish the degree and severity of mucositis. The correlations between the clinical data, type of cancer, and therapy were statistically analysed. Results. Mucositis was present in 88.23% of the patients; 57.78%, 7.78%, and 24.44% received QT, RT, and QT-RT, respectively. Severity scores of 1 and 2 were the most common; scores of 3-4 were observed in patients who received QT-RT or more than 7 treatment cycles. There was a significant association between mucositis, the type of treatment, and the number of cycles received (p<0.05). Conclusion. It is important to implement therapeutic protocols that help maintain excellent oral health and reduce the risk of oral mucositis. Stomatologists should be consulted to assess patients’ oral cavities and provide preventive treatment prior to QT and/or RT administration. It is important to integrate a stomatologist into the oncological working group to focus on preventing and managing oral mucositis.

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Clinical evaluations of pleiotropic effects of pravastatin

Atherosclerosis ◽

10.1016/s0021-9150(00)80338-x ◽

2000 ◽

Vol 151 (1) ◽

pp. 74

Author(s):

T Yamashita ◽

H Nakamura ◽

E Miyajima ◽

M Homma ◽

N Tada ◽

...

Keyword(s):

Pleiotropic Effects ◽

Clinical Evaluations

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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Pharmaceutics ◽

10.3390/pharmaceutics13010048 ◽

2020 ◽

Vol 13 (1) ◽

pp. 48

Author(s):

Ioana Gherghescu ◽

M. Begoña Delgado-Charro

Keyword(s):

Drug Administration ◽

Action Plan ◽

European Medicines Agency ◽

Patient Access ◽

Clinical Evaluations ◽

The Past ◽

The Us ◽

Improve Patient ◽

The Eu

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira’s exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’.

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Safety of hydroxychloroquine and darunavir or lopinavir in COVID-19 infection

Journal of Antimicrobial Chemotherapy ◽

10.1093/jac/dkaa441 ◽

2020 ◽

Author(s):

Etienne Meriglier ◽

Claire Rivoisy ◽

Mojgan Hessamfar ◽

Noelle Bernard ◽

Ines Aureau ◽

...

Keyword(s):

Cardiovascular Disease ◽

Cohort Study ◽

Clinical Practice ◽

Combination Therapy ◽

Observational Cohort Study ◽

Potential Drug ◽

Clinical Evaluations ◽

History Of ◽

Observational Cohort ◽

Ecg Abnormalities

Abstract Background Combination therapy with hydroxychloroquine and darunavir/ritonavir or lopinavir/ritonavir has been suggested as an approach to improve the outcome of patients with moderate/severe COVID-19 infection. Objectives To examine the safety of combination therapy with hydroxychloroquine and darunavir/ritonavir or lopinavir/ritonavir. Methods This was an observational cohort study of patients hospitalized for COVID-19 pneumonia treated with hydroxychloroquine and darunavir/ritonavir or lopinavir/ritonavir. Clinical evaluations, electrocardiograms and the pharmacokinetics of hydroxychloroquine, darunavir and lopinavir were examined according to clinical practice and guidelines. Results Twenty-one patients received hydroxychloroquine with lopinavir/ritonavir (median age 68 years; 10 males) and 25 received hydroxychloroquine with darunavir/ritonavir (median age 71 years; 15 males). During treatment, eight patients (17.4%) developed ECG abnormalities. Ten patients discontinued treatment, including seven for ECG abnormalities a median of 5 (range 2–6) days after starting treatment. All ECG abnormalities reversed 1–2 days after interrupting treatment. Four patients died within 14 days. ECG abnormalities were significantly associated with age over 70 years, coexisting conditions (such as hypertension, chronic cardiovascular disease and kidney failure) and initial potential drug interactions, but not with the hydroxychloroquine concentration. Conclusions Of the patients with COVID-19 who received hydroxychloroquine with lopinavir or darunavir, 17% had ECG abnormalities, mainly related to age or in those with a history of cardiovascular disease.

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Development and Validation of High-Content Analysis for Screening HDAC6-Selective Inhibitors

SLAS DISCOVERY Advancing Life Sciences ◽

10.1177/24725552211002463 ◽

2021 ◽

pp. 247255522110024

Author(s):

Yunhong Nong ◽

Yanyan Hou ◽

Yuting Pu ◽

Si Li ◽

Yan Lan

Keyword(s):

Content Analysis ◽

Adverse Effects ◽

Hdac Inhibitors ◽

Histone H3 ◽

Class I ◽

Cell Seeding ◽

Clinical Evaluations ◽

Structure Activity ◽

High Content Analysis ◽

Development And Validation

Throughout recent decades, histone deacetylase (HDAC) inhibitors have shown encouraging potential in cancer treatment, and several pan-HDAC inhibitors have been approved for treating malignant cancers. Numerous adverse effects of pan-HDAC inhibitors have been reported, however, during preclinical and clinical evaluations. To avoid undesirable responses, an increasing number of investigations are focusing on the development of isotype-selective HDAC inhibitors. In this study, we present an effective and quantitative cellular assay using high-content analysis (HCA) to determine compounds’ inhibition of the activity of HDAC6 and Class I HDAC isoforms, by detecting the acetylation of their corresponding substrates (i.e., α-tubulin and histone H3). Several conditions that are critical for HCA assays, such as cell seeding number, fixation and permeabilization reagent, and antibody dilution, have been fully validated in this study. We used selective HDAC6 inhibitors and inhibitors targeting different HDAC isoforms to optimize and validate the capability of the HCA assay. The results indicated that the HCA assay is a robust assay for quantifying compounds’ selectivity of HDAC6 and Class I HDAC isoforms in cells. Moreover, we screened a panel of compounds for HDAC6 selectivity using this HCA assay, which provided valuable information for the structure–activity relationship (SAR). In summary, our results suggest that the HCA assay is a powerful tool for screening selective HDAC6 inhibitors.

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Does an occupational physician have a duty to carry out general clinical assessments?

Medico-Legal Journal ◽

10.1177/00258172211024853 ◽

2021 ◽

pp. 002581722110248

Author(s):

Andrea Cioffi ◽

Raffaella Rinaldi

Keyword(s):

Health Risks ◽

Occupational Physician ◽

Professional Responsibility ◽

Patient Relationship ◽

Doctor Patient Relationship ◽

Clinical Assessments ◽

Work Related ◽

Clinical Evaluations

An occupational physician is employed to be responsible for the overall assessment of workers’ health risks and all work-related pathological situations which creates an unusual doctor–patient relationship. The duties of the occupational physician are also very limited as is their professional responsibility. However, the boundaries of the occupational physician’s duties and responsibilities are not always clear. The purpose of this article is to answer the following question: Does the occupational doctor have a duty to carry out general clinical evaluations (not work-related) of the patient?

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Approximation of the Kinematics of Foot Joints by Using Passive Elastic Characteristics of Joint

Key Engineering Materials ◽

10.4028/www.scientific.net/kem.342-343.621 ◽

2007 ◽

Vol 342-343 ◽

pp. 621-624

Author(s):

Hyeon Ki Choi ◽

Si Yeol Kim ◽

Won Hak Cho

Keyword(s):

Joint Angle ◽

Reaction Force ◽

Force Plate ◽

Least Square Method ◽

Least Square ◽

Biomechanical Analysis ◽

Clinical Evaluations ◽

Foot Joints ◽

The Relationship ◽

Elastic Characteristics

We investigated the relationship between kinematic and kinetic characteristics of foot joints resisting ground reaction force (GRF). Passive elastic characteristics of joint were obtained from the experiment using three cameras and one force plate. The relationship between joint angle and moment was mathematically modeled by using least square method. The calculated ranges of motion were 7o for TM joint, 4o for TT joint and 20o for MP joint. With the model that relates joint angle and plantar pressure, we could get the kinematic data of the joints which are not available from conventional motion analysis. The model can be used not only for biomechanical analysis which simulates gait but also for the clinical evaluations.

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